Clinical Policy Title: Tactile breast imaging

Transcription

1 Clinical Policy Title: Tactile breast imaging Clinical Policy Number: Effective Date: February 1, 2018 Initial Review Date: November 16, 2017 Most Recent Review Date: January 11, 2018 Next Review Date: January 2019 Policy contains: Breast cancer screening. Clinical breast exam. Palpation, mechanical, or stress imaging. Related policies: CP# Breast cancer screening in women ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state or plan specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas clinical policies are reflective of evidence based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas considers the use of tactile breast imaging with either of the following devices to be investigational and, therefore, not medically necessary: SureTouch Digital Breast Exam (Sure Inc., Los Angeles, California). ibreastexam (UE LifeSciences, Philadelphia, Pennsylvania). Limitations: All other uses of tactile breast imaging are not medically necessary. Alternative covered services: Mammography. Ultrasonography. 1

2 Magnetic resonance imaging (MRI). Background In 2017, an estimated 316,120 new cases of breast cancer will be diagnosed in women, including 63,410 new cases of the non invasive, early form carcinoma in situ (CIS) (American Cancer Society [ACS], 2017). Regular screening is the most reliable method for detecting breast cancer early when treatment is the most effective. Screening recommendations vary according to breast cancer risk, and several tools are available to approximate breast cancer risk based on various combinations of risk factors. Current methods of breast screening and diagnosis include breast self examination, clinical breast exam, ultrasonography, mammography, and MRI (Sarvazyan, 2012). The clinical breast exam often represents the first line of screening defense for monitoring breast health. A clinical breast exam includes visual inspection to identify physical signs of breast cancer (e.g., breast asymmetry and differences in skin color, texture, temperature, and venous patterns) and palpation of the breasts and lymph nodes (McDonald, 2004). There are limitations to a manual clinical breast exam that can influence the ease or difficulty of breast cancer detection (McDonald, 2004): Variation in palpation technique. Lack of standardized reporting. Tumor size, firmness, and location. Patient characteristics density, nodularity, and durity (compressibility) of breast tissue; menopausal status; body weight; hormone use; age; and race. Examiner training and proficiency. Tactile breast imaging: To overcome these limitations, tactile breast imaging was developed in the 1990s as a diagnostic modality based on digital 3 D reconstruction of structure and elastic properties of breast tissue using mechanical sensors that mimic the human fingertips during a clinical breast exam (Sarvazyan, 2012). Tactile imaging is a branch of elasticity imaging that captures stress data at different levels of compression, rather than dynamic or static strain data employed with ultrasonic and magnetic resonance technologies. During the breast examination, a handheld mechanical sensor is applied to the breast to record and store data in a digital format file (Sarvazyan, 2012). Tactile breast imaging quantifies and records the presence (or absence), size, shape, hardness, and location of breast lesions. It is also called mechanical imaging, palpation imaging, computerized palpation, or stress imaging. The duration of a typical lesion scan is approximately one to two minutes. The U.S. Food and Drug Administration (FDA) defines such a device as a breast lesion documentation system for use in producing a surface map of the breast as an aid to document 2

3 palpable breast lesions detected during a clinical breast exam (21CFR ). The FDA has issued 510(k) approval as Class II medical devices with special controls (product code NKA) to the following devices that employ proprietary elastography technology: SureTouch through a Section 513(f)(2) de novo process under the name BreastView Visual Mapping System (Assurance Medical, Washington, D.C.) in 2003 (FDA, 2017a). ibreastexam as a substantially equivalent device in 2015 (FDA, 2017b). Searches AmeriHealth Caritas searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on October 18, Search terms were: elasticity imaging techniques (MeSH), breast (MeSH), Ultrasonography, Mammary/methods (MAJR), and free text terms shear wave elastography, tactile breast imaging, digital breast exam, palpation imaging, and mechanical imaging. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings We identified two single arm studies and one meta analysis of nine studies presented as a meeting abstract for this policy. One study evaluated the diagnostic performance of the ibreastexam (Broach, 2016), and the other study and meta analysis focused on SureTouch (Kaufman, 2014; Tasoulis, 2014). The current evidence consists of very low quality, uncontrolled studies of the diagnostic efficacy for either tactile breast imaging device. The impact of these devices on patient outcomes has not been determined. There is significant potential for bias in these studies that could result in hyper inflated estimates of diagnostic accuracy of tactile breast imaging relative to other screening modalities. Limitations to the 3

4 research include insufficient reporting of the referral process and work up prior to tactile breast imaging, lack of randomization, unclear blinding, and inconsistent application of the gold standard (either radiology or histopathology). It is unclear where tactile breast imaging would fit into current screening algorithms, as a reliable comparison to mammography or clinical breast exam has not been made. The majority of patients enrolled in these studies were described as symptomatic based on prior work up or physical complaints, but the extent of the work up was not defined. The FDA approved the device as an aid for documenting palpable breast lesions detected during a clinical breast exam, but the value of a clinical breast exam has been questioned. Adjunctive clinical breast exam can detect approximately 2 percent to 6 percent more breast cancers than screening mammography alone, but its impact on extending survival or reducing breast cancer mortality is unclear (Oeffinger, 2015). As a result, guidelines disagree on recommendations for clinical breast exam in asymptomatic women at average risk 1 for breast cancer (The American Congress of Obstetricians and Gynecologists [ACOG], 2017; ACS, 2017; National Comprehensive Cancer Network [NCCN], 2017; U.S. Preventive Services Task Force [USPSTF], 2016). The quality of the evidence for tactile breast imaging would need to dramatically improve before its value in breast cancer screening can be determined. A phase II study is underway to compare the accuracy of the ibreastexam for the detection of clinically relevant findings in the breast to current mammography (clinicaltrials.gov identifier NCT ), and a phase 4 study of the clinical utility (accuracy) of the ibreastexam for the detection of breast lesions or lumps compared to the results of a current mammogram and/or ultrasound (clinicaltrials.gov identifier NCT ). Policy updates: None. Summary of clinical evidence: Citation Broach (2016) A cost-effective handheld breast scanner for use in low-resource environments: a validation study Content, Methods, Recommendations Key points: Case series of 77 females and one male presenting to a breast imaging center for a diagnostic work-up; mean age = 42 years (range 21 years 79 years). Patients evaluated by ultrasound (77), diagnostic mammography (52), and biopsy (39). Imaging and/or biopsy confirmed a mass (fibroadenoma, cyst, papilloma, myofibroblastoma, fat necrosis, ductal carcinoma in situ, or cancer) in 60 patients, of whom 12 patients had a cancer diagnosed. 1 A woman at average risk for breast cancer is one without a personal history of breast cancer; a strong family history of breast cancer; a genetic mutation known to increase risk of breast cancer (e.g., a BRCA gene); and no chest radiation therapy before age 30 (ACS, 2017). 4

5 Citation clinicaltrials.gov identifier: NCT ibreastexam Kaufman (2014) Content, Methods, Recommendations In total, 77 of 342 quadrants scanned had lesions confirmed on imaging. ibreastexam identified 66 of 77 lesions: sensitivity = 86%; specificity = 89%. Key points: Clinical studies of palpation imaging of the breast on more than 1,000 patients Meeting abstract SureTouch Meta-analysis of nine clinical studies involving 1,155 total symptomatic patients in the United States, China, and the United Kingdom comparing mammography, breast ultrasound, clinical breast exam, MRI, and tactile breast imaging to pathology. For identifying the presence of an abnormality, sensitivity of tactile breast imaging and clinical breast exam was 89% and 83%, respectively. For identifying the presence of breast cancer: Modality Sensitivity (%) Specificity (%) Accuracy (%) Tactile breast imaging Clinical breast exam Mammography Ultrasonography Tasoulis (2014) Key points: Diagnostic accuracy of tactile imaging in selecting patients with palpable breast abnormalities: a prospective comparative study SureTouch A prospective, blinded, comparative study of 276 consecutive patients comparing tactile breast imaging to clinical breast exam. Radiological findings and final diagnosis based on histology and/or cytology were used as reference standards, and receiver operator characteristic (ROC) curve analysis performed. Detection according to radiologically-proven abnormalities: Modality Sensitivity (%) Specificity (%) Tactile breast imaging Clinical breast exam Detection according to histology/cytology: Modality Sensitivity (%) Specificity (%) Tactile breast imaging Clinical breast exam ROC analysis suggests clinical breast exam was superior to tactile breast imaging. Subgroup analysis suggests superior sensitivity of tactile breast imaging in detecting a histological entity in pre-menopausal women. References Professional society guidelines/other: ACOG Practice Bulletin Number 179. Breast Cancer Risk Assessment and Screening in Average Risk Women. July ACOG website. And Publications/Practice Bulletins/Committee on Practice Bulletins Gynecology/Breast Cancer Risk Assessment and Screeningin Average Risk Women. Accessed October 20,

6 American Cancer Society Recommendations for the Early Detection of Breast Cancer ACS website. cancer/screening tests and early detection/american cancersociety recommendations for the early detection of breast cancer.html. Accessed October 24, Breast Cancer: Screening. Release date: January USPSTF website. cancerscreening1. Accessed October 30, FDA Device Classification under Section 513(f)(2) (de novo) database searched using product code NKA. FDA website. Accessed October 30, 2017.(a) FDA 510(k) Premarket Notification database searched using product code NKA. FDA website. Accessed October 30, 2017.(b) NCCN Guidelines Version Breast Cancer Screening and Diagnosis. NCCN website. Accessed October 20, Peer reviewed references: Broach RB, Geha R, Englander BS, et al. A cost effective handheld breast scanner for use in low resource environments: a validation study. World Journal of Surgical Oncology. 2016; 14: 277. DOI: /s Kaufman CS, Son JS, Yered E, Sarvazyan A. Clinical studies of palpation imaging of the breast on over 1000 patients. San Antonio Breast Cancer Symposium website. Accessed October 18, McDonald S, Saslow D, Alciati MH. Performance and Reporting of Clinical Breast Examination: A Review of the Literature. CA: A Cancer Journal for Clinicians. 2004; 54(6): DOI: /canjclin Nelson HD, Fu R, Cantor A, et al. Effectiveness of Breast Cancer Screening: Systematic Review and Metaanalysis to Update the 2009 U.S. Preventive Services Task Force Recommendation. Ann Intern Med. 2016; 164(4): DOI: /M Oeffinger KC, Fontham EH, Etzioni R, et al. Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. Jama. 2015; 314(15): DOI: /jama

7 Tactile Sensing and Tactile Imaging in Detection of Cancer. Taylor and Francis website /tactile_imaging.pdf. Accessed October 24, Tasoulis MK, Zacharioudakis KE, Dimopoulos NG, Hadjiminas DJ. Diagnostic accuracy of tactile imaging in selecting patients with palpable breast abnormalities: a prospective comparative study. Breast Cancer Res Treat. 2014; 147(3): DOI: /s CMS National Coverage Determinations (NCDs): Mammograms. CMS website. coverage database/details/ncddetails.aspx?ncdid=186&ver=1. Access October 25, Local Coverage Determinations (LCDs): L33950 Breast Imaging Mammography/Breast Echography (Sonography)/Breast MRI/Ductography. CMS website. coverage database/details/lcddetails.aspx?lcdid=33950&ver=17. Accessed October 25, L33585 Breast Imaging: Breast Echography (Sonography)/Breast MRI/Ductography. CMS website. coverage database/details/lcd details.aspx?lcdid=33585&ver=22. Accessed October 25, Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. The American Medical Association has given it a Category III (043XTI) code, Tactile breast Imaging by computer aided tactile sensors, unilateral or bilateral. CPT Code Description Comments 0422T Tactile breast imaging by computer-aided tactile sensors, unilateral or bilateral ICD-10 Code Description Comments N63.0-N63.14 Unspecified lump in the right breast N63.20-N63.24 Unspecified lump in the left breast N63.31-N63.32 Unspecified lump in axillary tail N63.41-N63.42 Unspecified lump in breast, subareolar 7

8 HCPCS Level II Code N/A Description Not Applicable Comments 8